Analysis of Wyeth versus Levine Court Case - Research Paper Example

Wyeth vs. Levine Court Case Legal issues concerning pharmaceutical products tend to be sensitive and compounded by a host of complexities. This is attributable to the damages and losses that they impose on the affected individuals. Notably, the relative negative effects have lasting implications on the wellbeing of the population. For this reason, they are often accorded utmost attention by the legal institutions reviewing them. In this case, Diana Levine, a Vermont Guitarist sued Wyeth manufacturing company for the losses she suffered after her arm was amputated due to the effects of a drug that had been improperly administered. This began in April, 2000 when the complainant suffered from nausea that was reportedly caused by a migraine headache. She decided to seek medical treatment from a health clinic. Here, she was injected two doses of phenergan, a drug that is manufactured by Wyeth. During the first administration, the drug was given through intramuscular injection. This according to the label, this was the most preferable method. However, her nausea persisted and to counter this, she was given another dose through IV push. In this, drugs are administered directly into the patient’s vein in a bid to promote fast relief. Accidentally, it was administered into Levine’s vein and thus causing irreversible gangrene. Consequently, her forearm as well as right arm was amputated. She began by settling the matter with the clinic and then proceeded to sue the manufacturer for negligence as well as strict liability in a court of law. In this, she alleged that the manufacturer failed to provide critical information regarding the negative implications associated with the IV push administration method. A judge overseeing this case ruled in favor of the complainant. This decision was further affirmed by the supreme court of Vermont. In this case, Levine argued that the information provided by the label did not address the effects of the IV push methodology. Although it placed great emphasis on the relative gangrene risk that could stem from an inadvertent intra-arterial injection, the respective label did not offer any information regarding the concept of IV push. Further, it did not provide any information related to the prohibition of this method og administration. Levine’s insisted that the company had the responsibility of providing this important information by labeling the drug through ‘Changes Being Effected’ provisions. These according to Constance and Savage all drug manufacturers to add any new safety related information to a product without the approval of Food and Drug Administration (FDA) authority (Constance and Savage 47). From its point of view, Wyeth argued that with reference to FDA’s review and relative approval of the phenergan’s label, Levine’s claims regarding the adequacy of label concern were preempted. In this respect, FDA had previously evaluated the product as well as its labeling. Since the 1950’s, the authority had been satisfied that the label provided sufficient information in the label that covered the IV Push method too. As aforementioned, the judge ruled in favor of the complainant. According to him, the approval of this label was not enough to prevent the company from strengthening the warning on the label (Christophe 49). In essence, the company was at liberty to provide more information that it deemed critical in the label. Levine was awarded millions in damage by a jury. The court’s majority believed that Wyeth had the responsibility of updating the information based on the analyses of any recent data. In this regard, it maintained that Wyeth could have reviewed the amputation statistics and using relative deductions, added important information to the label. This from its point of view could be done without the approval of the court. These according to the court were important state regulations that needed to be adhered to by Wyeth regardless of the absence of approval from FDA. Furthermore, the court believed that information added on the label could possibly not have been rejected by FDA because it was critical and very sensitive. The court also considered Wyeth’s understanding of the CBE regulation and assertion that unilateral change of drug labels could violate the federal laws governing illegal misbranding and distribution of drugs to be cramped. According to Ashutosh, interpretation of this law by Wyeth was wrong (Ashutosh 198). This is because in light of FDA’s provisions, the manufacturer of the pharmaceutical products has a central role to play in drug labeling. This is particularly so in instances where failure to label can have lasting detrimental effects on the patients. In this respect, it is worth appreciating that the Food, Drug and Cosmetic Act considers the manufacturer to be responsible for any content contained in the label at all times too. Wyeth argued that if it assumed this responsibility, this would interfere with the states strongest agency’s role with regard to labeling pharmaceutical products. The court considered this meritless as it undermines the congress’ intention with respect to protecting the consumer base. From its point of view, Wyeth to begin with, the congress had not preempted the state tort actions contained in the FDCA. In addition, it did not intent that the FDCA fully occupies the prescription sphere in relation to drug regulation. In essence, this case was controversial and any action by Wyeth could have amounted to implied conflict preemption. In its arguments, Wyeth maintained that it could possibly not use the required label that was also approved by the FDA and then comply with state common law rules at the same time. These rules according to Curfman, Morrisey and Jeffery required it to provide stronger warnings regarding the IV Push method (Curfman, Morrisey and Jeffery 2) Further, Wyeth indicated that by legally punishing the drug manufacturing companies for effectively using FDA approved labels, the tort claims that had been set forth by the complainant undermined the credibility of FDCA in the execution of its duties. Although these two provisions are very important, they need to be balanced effectively in order to prevent conflicts that could compromise the legality as well as credibility of one body. Also worth putting in consideration according to the defendant was the fact that taking any drugs had various health risks to the patient. It is therefore vital for the patient to acknowledge that the risks can have adverse impacts on their holistic wellbeing. The decision of the court had varied implications on the drug manufacturing companies, relative regulatory and policy institutions and the members of the public at large. Notably, all these have a distinct role to play in order to prevent any conflicts that can undermine the functioning of any. Undoubtedly, the pain suffered by Levine was intense. Losses relating to loss of a career and ability to perform optimally were very significant. They undermined her quality of life and have lasting impacts on her life in general. To a great extent, the intrinsic value of these cannot be compared to the millions that she was accorded by the court as compensation. Although she would be satisfied in the short term, it would be difficult for her to lead a fulfilling life like she would have if she could not have lost her forearm and hand. According to Epstein and Greve, Wyeth has also suffered significant financial losses that emanate from its negligent tendencies (Epstein and Greve 51). From the case study, it has been compelled to pay the complainant millions of money in compensation. The institutions clearly understood the limitations of the drug. It was responsible for monitoring the performance of the drug and taking practical measures to counter negative effects. In addition, it was its moral responsibility to inform the public about relative risks and offer viable options that would help them maintain healthy living. Being a business entity, the relative losses greatly undermine its ability to compete favorably in the current market. At this point, it is worth noting that the business environment has become increasingly competitive. Various companies are therefore taking measures to ensure optimal functioning. One of these measures pertains to the reduction of costs or expenses at all levels of the supply chain. The losses that this company encountered at this point in time were therefore potentially damaging and could have been avoided altogether. This ruling ascertains the fact that drug manufacturers, as opposed to the FDA have the sole responsibility of monitoring and updating drug labeling. This includes timely identification of any risk and effective communication of this to the public. To prevent the recurrence of such scenarios in future, Smith posits that manufacturers should provide a comprehensive guide to the FDA especially regarding possible products risks accordingly (Smith 19). This should comprehensively demonstrate the processes they would take to evaluate the risks accordingly. To prevent liability, this should be done prior to the approval by the FDA. In his research, Curfman et al indicates that manufacturers of drugs need to place great attention to the risks that are associated with their drugs (Curfman et al 2). In particular, they should evaluate the performance of the drug and identify any negative impacts that are associated with its use. This case demonstrates the grave effects that drugs can have on the health and general wellbeing of the patients. They are actually poisonous substances that impact on the overall functioning of the human body. This particularly happens in instances when they are administered inappropriately or consumed in wrong doses. Amongst other methods of information dissemination, drug manufacturers need to update the labels on their drugs accordingly. In his research, Smith found out that 81% of the patients and other drug users rely heavily on the information provided in the labels for decision making (Smith 24). Different professionals also rely on the relative information especially during the administration of the drugs to the users. This implies that the respective information is vitally important and needs to be comprehensive as well as accurate. This would help in ensuring that decisions made in this respect are based on informed thought. Credible information in this regard can be sourced from periodic statistics that are done by the companies. Arguably, the congress acknowledges the role that regulatory bodies such as the FDA play in drug labeling. By according the manufacturers this responsibility, Christophe indicates that the courts appreciate that manufacturers have first hand information about the functioning of the drug (Christophe 38). Compared to other bodies, they appreciate that these have the ability to perform their duties thoroughly, consistently and persuasively. If a clear balance is struck between the two, conflicts can be avoided at all costs and all bodies can work effectively towards achieving a common goal. This ruling also has direct effects on pharmaceutical products as well as other consumer products that are regulated by different other agencies. This is important as it could go a long way in protecting the consumer about the effects of negligent practices exhibited by the manufacturers. In his research, Ashutosh maintains that the decision that was undertaken by the court in this respect was credible (Ashutosh 215). In this regard, this could bear better results because compared to the regulatory bodies, the drug manufacturers have the greatest impact on the quality of the products that they offer in the market. The ruling can possibly make drug manufacturers more responsible of their decisions and operations. At this point, it is worth appreciating that these are business entities whose sole aim is to make profits. Implementing relative regulations and policies would make them focus more on the safety of the public. In his research, Christophe argues that the losses that the manufacturing company in this case suffered were intense (Christophe 81). From this point of view, this is detrimental in the sense that it discourages creativity and innovation and raises the prices of the drugs. Moreover, relative implications deny the clients a chance to access affordable yet effective medicines. The two regulatory regimes in this regard have various expectations whose pursuit by the companies culminate in wide ranging and potentially damaging conflicts. From this point of view, it is vital that the congress in conjunction with other legal bodies clearly underscore the roles and responsibilities of each body. This would ensure effective functioning of both bodies without fear of infringing on the rights of either. Also worth mentioning is the competence of medical practitioners in the execution of their duties. In the preceding case, Constance and Savage believe that the medical practitioner who administered the drug was unprofessional (Constance and Savage 69). It cannot be disputed that he was well versed with the negative implications associated with wrong administration of the drug. Thus s/he would have equally shouldered the costs related to the losses incurred by Levine. In conclusion, this case provides useful insights regarding the role of manufacturing companies in drug labeling. In this Levine sued Wyeth manufacturing Company for negligence. Seemingly, the company failed to provide important information about the effects of possible wrong administration of the drug on its label. The resultant effects saw the complainant losses her forearm and right hand. Other losses related to loss of career and ability to function optimally. The court ruled in favor of Levine and she was compensated in millions. The court underscores the negative effects related to dual functioning of two regulatory bodies. As Wyeth puts it, its failure to update labels was partly contributed to by the fact that its labels had been previously been approved by FDA. However, it still has the responsibility of providing this information to the public. Works Cited Ashutosh Bhagwat. Wyeth v Levine and agency preemption: More muddle or creeping to clarity. Tulsa Law Review, 45.2 (2009): 197-232. Print. Christophe Drahozal. The supremacy clause: A reference guide to the United States constitution. USA: Praeger, 2004. Print. Constance Bagley and Savage Diane. Managers and the legal environment: Strategies for the 21st Century. USA: South-Western Publishers, 2009. Curfman Gregory, Morrissey Stephen and Jeffrey Drazen. Why doctors should worry about preemption. New England Journal of Medicine, 359.1 (2008): 1-3. Print. Epstein Richard and Greve Michael. Federal preemption: States powers, national interests. USA: Aei Press, 2007. Print. Smith Douglas. Preemption after Wyeth v Levine. Ohio State Law Journal, 70.6 (2009): 17-25. Print. Read More